Tuesday, March 18: Full Day workshop descriptions

Workshops W1, W2, and W3 are full day workshops.

:: Workshop 1

QSR with Comparison to the ISO9001/ISO13485 Standard

Russ Ziebell

About the workshop: This workshop for management and auditors provides a detailed overview of FDA’s QSR) with comparisons to ISO 9001 and ISO 13485. Participants will gain basic understanding of the QSR from a business operations model and an audit application standpoint. They also will learn how QSR can be mapped to ISO 9001/ISO 13485 with the intention of merging the systems.

About the instructor: Russ Ziebell has been a management consultant in compliance management systems for quality, environment, health and safety since 1992. Mr. Ziebell started River Systems in 1997 and with his partner formed in 1999 an internationally recognized training company called QAI that specializes in ISO 9001, QS/TS16949, AS9000/9100, ISO 13485, Six Sigma, Environment ISO 14001 and Health & Safety OHSAS 18001 Management System training. Russ has authored and delivered the internationally recognized ISO 9000/ISO 13485 Certified Lead Auditor Training program, accredited through the U.S. National Registration Accreditation Board (RABQSA) for QAI. Russ is also a RABQSA Certified Lead Auditor and has worked for KEMA Quality Registrars Inc. and is presently a RABQSA Skills Examiner. He has been an adjunct professor at the University of Wisconsin-Stout and Hennepin Technical College.

Level: Basic to Intermediate

:: Workshop 2

Integrated Auditing

Dennis Arter - (The Audit Guy)

Integrated Internal Auditing will explore ways to combine quality, safety, environment, and security audits under one umbrella program. This follows the Process-Based Auditing approach with lecture and workshop. Participants will actually develop some of the unknown methods in their small work groups to see how best to approach Biomedical audits. This workshop is NEW and would be $1000 a day in other venues.

Level: Basic

:: Workshop 3

DOE Case Studies in the Biomedical Industry

Pat Whitcomb

See how design of experiments (DOE) is being applied in the medical device and pharmaceutical industries. Case studies demonstrate applications in research and development, assay development, characterization of drug stability, etc. The examples include a variety of simple to complex designs that will get you thinking about how DOE can improve your own experimental efforts.

Level: Intermediate

Tuesday, March 18: Half Day workshop descriptions

Workshops W7 and W8 held 12:30 pm – 4:00 pm
Workshops W 4, W5 and W6 held 8:00 am – 11:30 am

:: Workshop 4

Living in Interesting Times: The Global Regulatory Environment Today and Tomorrow

Mike Morton

This presentation will examine recent changes in device regulation in key markets across the world. Important changes in regions such as the United States, the European Union, India, and China, will be addressed. Specific topics will be examined, such as the FDA Amendments Act of 2007. The presentation will then take a broader, more global view, and examine how changes in one or two regulated areas often impact other parts of the world. Themes such as oversight of the regulatory agencies, environmental requirements, reporting of adverse events, release of confidential information, and labeling will be examined. The presentation will conclude with a look at the influence of the FDA in shaping regulation around the world.

Level: Basic to Intermediate

:: Workshop 5

CAPA

Ashweni Sahni

Corrective and Preventive Action (CAPA) is one of the most important part of a quality system. That is why internal and external auditors always examine it, to gauge the strength of quality system. The speaker in this session will discuss important elements needed to design and implement an effective CAPA system.

Level: Basic

:: Workshop 6

Preliminary Hazard Analysis

Andre Routh

Discover better ways to do Hazard Analysis. Attend this workshop and improve the way your team and company can operate. Don’t miss it.

Level: Basic

:: Workshop 7

DFTS, CMMI and FDA's Software Validation Requirements

Jayaswal & Dr Peter Patton - Winners of the Crosby Medal from ASQ in 2008

The workshop will be based on the tenet that software quality and reliability issues are fundamentally similar to those in hardware and manufactured products. Current software development processes are largely faulty and we show that software must be produced differently if you must deliver trustworthy software. The goal of software quality should become that of preventing bugs in implementation rather than finding and eliminating them during and after implementation. A new technology, Design for Trustworthy Software (DFTS) will be presented. It consists of Robust Software Development Model (RSDM) and various upstream customer oriented methods, all of which may be applied before a single line of code is written! The DFTS technology and, particularly, its development model, RSDM, are central to producing trustworthy software in a cost-effective and viable manner.

Level: Basic to Intermediate

Bios

Bijay Jayaswal is the CEO of Agilenty Consulting Group, LLC. He has held senior executive positions and has consulted in quality and strategy for the last 25 years. His consulting and research interests include value engineering, process improvement and product development. He has taught engineering and management at the University of Mauritius and California State University, Chico and has directed MBA and Advanced Management programs. He has helped introduce corporate-wide initiatives in re-engineering, Six Sigma, and Design for Six Sigma and has worked with senior executive teams for effective implementation of such initiatives. He holds an MBA and a Master's degree in electrical engineering from Aston University in England. He can be reached at: bijay.jayaswal@agilenty.com.

Dr. Peter Patton is Chairman of Agilenty Consulting Group and has recently retired as Professor of Computer Science at the University of St. Thomas. He has also taught at the Universities of Minnesota, Paris and Stuttgart and has held the position of Chief Information Officer at the University of Pennsylvania. He was Chief Technologist at Lawson Software from 1996 to 2002 and Lawson representative on the Technical Advisory Committee of the IBM SanFranciscoTM Java Framework project. He has been involved in computer hardware and software development since 1955. He has engineering and mathematics degrees from Harvard, Kansas, and Stuttgart. His email contact is: peter.patton@agilenty.com.

Bijay and Peter are recipients of the American Society for Quality’s ASQ Crosby Medal for 2007 for their book, Design for Trustworthy Software. Their publications on software quality are listed below:

http://www.informit.com/search/index.aspx?size=10&docstart=1&searchmethod=Store&query=jayaswal&searchorder=Relevance&searchgrouptype=All&searchimprint=All&imageField.x=136&imageField.y=4

:: Workshop 8

FMEA - A Risk Management Tool

Angelo Scangas

Your ability to predict and evaluate potential failure modes is crucial. Whether you work in a complex engineering and manufacturing environment, or a process-oriented one, such as a hospital, laboratory or school system this course will benefit you. Utilizing FMEA to successfully determine failure mode cause and effect, will help you prevent the threat of potentially damaging failure modes.

Level: Basic